BOX 1.1Scientific Milestones for the Development of a Gene Sequence-Based Classification System for Oversight of Select Agents

Statement of Task

NIH has requested the National Research Council to convene an ad hoc committee to identify the scientific advances that would be necessary to permit serious consideration of developing and implementing an oversight system for Select Agents that is based on predicted features and properties encoded by nucleic acids rather than a relatively static list of specific agents and taxonomic definitions. The committee is asked to address several questions:

  • What would be the key scientific attributes of a predictive oversight system?
  • What are the challenges in attempting to predict biological characteristics from sequence?
  • Does the current state of the science of predicting function from sequence support a predictive oversight system at this time?
  • If not, what are the scientific milestones that would need to be realized before a predictive oversight system might be feasible?
  • In qualitative terms, what level of certainty would be needed about the ability to predict biological characteristics from sequence data in order to have confidence in a predictive oversight system?
  • In what time frame might these milestones be realized? What kinds of studies are needed to achieve these milestones?

From: 1, The Select Agent Regulations

Cover of Sequence-Based Classification of Select Agents
Sequence-Based Classification of Select Agents: A Brighter Line.
National Research Council (US) Committee on Scientific Milestones for the Development of a Gene Sequence-Based Classification System for the Oversight of Select Agents.
Washington (DC): National Academies Press (US); 2010.
Copyright © 2010, National Academy of Sciences.

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